MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS 2000; SUBSYSTEM, WATER PURIFICATION

Catalog Number G02040107-US

Device Problems Thermal Decomposition of Device (1071); Melted (1385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2022

Event Type  malfunction  

Event Description

A user facility biomedical technician (biomed) reported finding thermal damage on the main power contactor (q2) and the f1 p5 pump switch.Prior to the clinic opening, the biomed was informed by facility staff when they arrived in the morning that the heat disinfect had not been performed on the aquabplus 2000.The biomed indicated that it had been two weeks since the heat disinfect was last run.In addition, the following alarm code was displaying on the reverse osmosis (ro) system: w-04-52-01.Upon opening the hf cabinet for further inspection, the biomed found evidence of severe heat damage (melting and charring).The biomed stated the ro was fine and had not sustained any damage.An independent electrician went onsite to evaluate the setup and determined that the connection of the main contactor in the hf module was not secure.The biomed contacted a water systems service specialist who dispatched a field technician to the site.Upon evaluation of the damage, the field technician told the biomed they had never seen anything like it before.The technician provided a replacement hf module for the facility and took back the damaged one.The technician stated they would be returning the device to the manufacturer for further evaluation.The biomed did not observe any evidence of smoke, sparks, or flames.Furthermore, there were no reports of damage in the local power supply and there were no blown fuses.The biomed also confirmed there were no known power grid issues in the area around the date of the event.Photos of the damage were provided for review, along with the machine files.

Manufacturer Narrative

No death, serious injury, and no evidence of reportable product malfunction.

Manufacturer Narrative

Plant investigation: the contactor sample was returned for physical investigation.Based on the sample investigation and the provided pictures and machine files, the reported event can be confirmed.The complaint investigation revealed that (probably) a bad electrical contact at contactor q2 caused this issue.The source of the heat damage was at contactor q2.A bad electrical contact may be caused by clamping the wire insulation or loosening screws on the contactor.Another source of error could be vibrations sustained during transport and operation which can lead to the loosening of the screw terminals.It¿s also possible that during installation, the technician forgot to tighten the screws.This issue is known; however, due to a low failure rate no corrective/preventive actions will be required.During the sample investigation, it was determined that the inner contact 2 at the contactor q2 was defective.Due to the interrupted contact 2, the heaters only worked in phase 1 and phase 3.Heater 2 was able to pass the t1 test despite interrupted contact 2.This was most likely because the higher power (3.5 kw) of heater 2.Heater 1 (3 kw) was not able to pass the t1-test due to the lower power and the reported error code w-04-52-01 occurred.The following warnings were all logged at the same time and are follow up warnings.¿w-02-52-02 ¿ heating phase complete, ¿w-02-52-03 ¿ heat disinfection stopped¿, and ¿w-02-52-01 ¿ temperature not reached¿ - the adjusted return temperature of 80°c was not reached within 120min heating time.The provided contactor q2 was investigated visually and functionally.The reported event could be confirmed.Most likely, bad electrical contact (high contact resistance) led to high power dissipation, which caused the heat damage.A device history record (dhr) review was also performed.Based on the information available, the reported event was confirmed.

Event Description

A user facility biomedical technician (biomed) reported finding thermal damage on the main power contactor (q2) and the f1 p5 pump switch.Prior to the clinic opening, the biomed was informed by facility staff when they arrived in the morning that the heat disinfect had not been performed on the aquabplus 2000.The biomed indicated that it had been two weeks since the heat disinfect was last run.In addition, the following alarm code was displaying on the reverse osmosis (ro) system: w-04-52-01.Upon opening the hf cabinet for further inspection, the biomed found evidence of severe heat damage (melting and charring).The biomed stated the ro was fine and had not sustained any damage.An independent electrician went onsite to evaluate the setup and determined that the connection of the main contactor in the hf module was not secure.The biomed contacted a water systems service specialist who dispatched a field technician to the site.Upon evaluation of the damage, the field technician told the biomed they had never seen anything like it before.The technician provided a replacement hf module for the facility and took back the damaged one.The technician stated they would be returning the device to the manufacturer for further evaluation.The biomed did not observe any evidence of smoke, sparks, or flames.Furthermore, there were no reports of damage in the local power supply and there were no blown fuses.The biomed also confirmed there were no known power grid issues in the area around the date of the event.Photos of the damage were provided for review, along with the machine files.

Manufacturer Narrative

Correction: the following statement was erroneously included in the initial mdr: "no death, serious injury, and no evidence of reportable product malfunction." the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A user facility biomedical technician (biomed) reported finding thermal damage on the main power contactor (q2) and the f1 p5 pump switch.Prior to the clinic opening, the biomed was informed by facility staff when they arrived in the morning that the heat disinfect had not been performed on the aquabplus 2000.The biomed indicated that it had been two weeks since the heat disinfect was last run.In addition, the following alarm code was displaying on the reverse osmosis (ro) system: w-04-52-01.Upon opening the hf cabinet for further inspection, the biomed found evidence of severe heat damage (melting and charring).The biomed stated the ro was fine and had not sustained any damage.An independent electrician went onsite to evaluate the setup and determined that the connection of the main contactor in the hf module was not secure.The biomed contacted a water systems service specialist who dispatched a field technician to the site.Upon evaluation of the damage, the field technician told the biomed they had never seen anything like it before.The technician provided a replacement hf module for the facility and took back the damaged one.The technician stated they would be returning the device to the manufacturer for further evaluation.The biomed did not observe any evidence of smoke, sparks, or flames.Furthermore, there were no reports of damage in the local power supply and there were no blown fuses.The biomed also confirmed there were no known power grid issues in the area around the date of the event.Photos of the damage were provided for review, along with the machine files.

• Brand Name: AQUABPLUS 2000
• Type of Device: SUBSYSTEM, WATER PURIFICATION
• Manufacturer (Section D): VIVONIC GMBH; kurufuerst-eppstein-ring 4; sailauf 63877 ; GM 63877
• Manufacturer (Section G): VIVONIC GMBH; kurufuerst-eppstein-ring 4; sailauf 63877 ; GM 63877
• Manufacturer Contact: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13737702
• MDR Text Key: 287039914
• Report Number: 3010850471-2022-00006
• Device Sequence Number: 1
• Product Code: FIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: G02040107-US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1